Featured Articles
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Complex Parenteral Drug Manufacturing — A Foundation For Success
6/11/2020
A first-hand account of what it takes to develop and manufacture complex parenteral drugs.
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Client Oriented Project Management
8/5/2020
With the significant amount of outsourcing being done by the pharmaceutical industry, we believe project management has earned the right to be a critical factor in CDMO selection and deserves some exploration and understanding. Over our 26-year history and having successfully completed over 400 development projects, Pii has developed and refined project management operations to ensure outcomes are achieved and client expectations are exceeded. We have found that excellent project management has seven distinct features.
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Understanding Emergency Use Authorization (EUA)
Emergency Use Authorization (EUA) is a term that became part of the COVID-19 daily news briefings. What exactly is EUA? When is it used? How do the public health community, FDA, and drug developers authorize emergency use of drugs or other medical products?
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Managing Risks With Potent Pharmaceutical Products
7/2/2019
Any drug manufacturing facility handling potent compounds must be equipped with the appropriate methods, controls, and expertise to ensure the safety of its employees and the integrity of its product. Managing these risks requires a knowledgeable team as well as the design and implementation of an effective safety program.
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Meet The Scientist — Sam Chia
Sam is responsible for the sterile injectables facility, including four manufacturing suites and housing R&D, quality control, microbiology, and engineering support. He believes his role is most importantly about people – his colleagues and the patients who rely on the drug therapies they develop and manufacture.
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Self-Injection Of Biologics Made Easy
6/17/2022
Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
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Parenteral Drug Manufacturing — Innovation Begins With A Problem
6/11/2020
Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.
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Managing Small Batch Formulations
An understanding of critical process parameters and impact on quality attributes related to the finished form can be especially challenging when working with a limited amount of an API.
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Innovating During The COVID-19 Pandemic
Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds.
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Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity Controlled Pharma Company
The role of Chief Financial Officer for a small-to-mid size pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.